FDA 510(k)

Haymaker® Screw System

Номер K: K222799 · 2023-01-10

ЗаявительOrthocircle Spine D.B.A. OC Medical Devices

Дата решения2023-01-10

Код продуктаHWC

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

Haymaker® Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Orthocircle Spine D.B.A. OC Medical Devices. It received FDA 510(k) clearance on 2023-01-10 under 510(k) number K222799. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Haymaker® Screw System?

Haymaker® Screw System is a medical device that received FDA 510(k) clearance on 2023-01-10. The listed applicant is Orthocircle Spine D.B.A. OC Medical Devices. The 510(k) number is K222799.

When did Haymaker® Screw System receive FDA 510(k) clearance?

Haymaker® Screw System received FDA 510(k) clearance on 2023-01-10, under 510(k) number K222799.

Who is the listed applicant for Haymaker® Screw System?

The FDA 510(k) record lists Orthocircle Spine D.B.A. OC Medical Devices as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Haymaker® Screw System?

The FDA product code for Haymaker® Screw System is HWC. This falls under the Cardiovascular category.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: HWC)

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps Ortho K261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped K262344Large Compression ScrewsTriMed, Inc.

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.